Submission for OMB Review; 30 Day Comment Request Application Process for Clinical Research Training and Medical Education at the Clinical Center and Its Impact on Course and Training Program Enrollment and Effectiveness (Clinical Center), 39199-39200 [2020-14057]
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khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 85, No. 126 / Tuesday, June 30, 2020 / Notices
be required to meet the following
general requirements:
• Testing must be performed in a
CLIA-certified or -accredited laboratory
located in the United States.
• Assays can be on tumor tissue
(including lymphoma) or circulating
tumor DNA (ctDNA).
• Laboratory NGS panels must be
analytically and clinically validated on
DNA from human tumor tissues, with
performance characteristics as follows:
Æ Specificity at least 99% for single
nucleotide variants, indels
Æ Sensitivity at least 95% for single
nucleotide variants, indels
Æ Sensitivity of 90% for copy number
variants (state fold of copy number
variants that can be detected with
90% sensitivity)
Æ 99% reproducibility between
sequencers (if more than one
sequencer is used) and between
operators
Æ Lower limit of detection for SNV,
indels, CNV must be stated.
Laboratories must supply the
following information in their
application:
Æ Lower limit of % tumor accepted,
and whether (and which)
enrichment procedures are
employed
Æ Whether the lab archives images of
slides from the tumor
Æ Whether the lab also runs germline
as well as tumor with the assay (a
simultaneous germline sequencing
is not required by NCIComboMATCH)
Æ A detailed description of assay
procedures, including starting
material, extraction of nucleic
acids, quality assurance, quality
metrics, data analysis and filters
must be supplied.
• Laboratory NGS test panels must
interrogate actionable mutations of
interest (aMOIs) required for enrollment
into the available variant arms.
Applicant laboratories must state which
NCI-ComboMATCH arms they would
like to participate in.
• Academic laboratories must be
located at a center that participates in
NCI-ComboMATCH.
• The designated lab should be
willing to provide residual nucleic acid
from the sample they tested if the
patient enrolls on NCI-ComboMATCH.
• Laboratories shall NOT advertise
that they are screening laboratories for
ComboMATCH eligibility without prior
review by NCI and ECOG–ACRIN. Any
press release or public disclosure
requires clearance by NCI and the NCIComboMATCH team.
• Laboratories must agree to use the
existing workflow established by the
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NCI NCI-ComboMATCH trial team to
identify patients for the variant arms.
Æ Laboratory results of NGS assays
done for clinical care will be the
subject of this initiative. There is no
funding for ‘‘screening’’ a patient
for NCI-ComboMATCH.
Æ Laboratories must notify NCIComboMATCH sites that the
laboratory results would potentially
allow the patient to be eligible for
NCI Combo MATCH.
Æ Laboratories must track how many
assays per month detect rare
variants that could make a pediatric
patient eligible for NCIComboMATCH.
Æ If the clinician presents the NCIComboMATCH study and the
patient is eligible and desires to
enter the study, the laboratory must
agree to enter results into the
informatics system that assigns
treatment in Combo MATCH
(MATCHbox).
Æ Laboratories must have a way to
answer questions from Combo
MATCH sites about their assay and
must have a contact person for
optimal communication with the
NCI-ComboMATCH team.
• Prior to participation, laboratories
must enter into a collaboration
agreement with NCI. A sample
agreement is available upon request. As
part of such a collaboration agreement,
laboratories must agree to provide the
licensing rights described in the CTEP
IP Option to the Pharmaceutical
Collaborators who provided agents for
the NCI-ComboMATCH trial (https://
ctep.cancer.gov/branches/rab/
intellectual_property_option_to_
collaborators.htm) as well as agree to
the data sharing and publication rights
consistent with those agreements.
• No reimbursement for these
activities (testing or notification of sites
of NCI-ComboMATCH eligibility) exists.
Qualified laboratories serving
underserved populations are
encouraged to participate.
How to apply:
1. Submit letter of interest (LOI) as
described above under ‘‘Letter of
Interest and Confidentiality Agreement’’
to NCICOMBOMATCHLabApps@
nih.gov.
2. LOIs will be accepted for 3 months
from the date of this notice. LOIs will
be reviewed immediately upon receipt.
3. Notification of acceptance, nonacceptance or questions from Steering
Committee will be sent to the
designated contact person as soon as the
LOI has been reviewed. This
notification will include further
instructions if a full application is
invited.
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39199
4. Applications that have not been
submitted within 6 weeks of notification
of acceptance of the LOI will be deactivated and not further considered.
5. DO NOT send a full application
until you are invited to do so.
Review criteria for LOI:
Laboratory is a CLIA certified
laboratory within the United States.
Academic laboratories must have NCIComboMATCH open at their site.
Laboratory NGS assay has adequate
sensitivity and specificity.
Laboratory tests tumor tissue for rare
variants as described in NCIComboMATCH.
Laboratory agrees to provide needed
information for evaluation of the
analytical validity of the test.
Laboratory is likely to screen at least
250 pediatric patients at NCTN sites for
NCI-ComboMATCH per month.
Laboratory agrees to contact sites
regarding NCI-ComboMATCH
eligibility.
Laboratory agrees to a collaboration
with NCI as detailed above.
Review criteria for full application:
Laboratory supplies evidence that the
assay meets analytical requirements as
detailed above.
Laboratories are capable of contacting
clinical sites, tracking activity, and of
screening at least 250 pediatric patients
at NCTN sites per month to the study
based on detection of potential variants.
Laboratories agree to execute a
collaboration agreement with NCI, as
well as to data sharing and sharing
publication rights.
Laboratories agree to abide by the
procedures in place for the NCIComboMATCH study and to collaborate
fully with the NCI-ComboMATCH team.
For more information, contact
NCICOMBOMATCHLabApps@nih.gov.
Dated: June 24, 2020.
James V. Tricoli,
Chief, Diagnostic Biomarkers and Technology
Branch, Cancer Diagnosis Program, National
Cancer Institute.
[FR Doc. 2020–14043 Filed 6–29–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30 Day
Comment Request Application
Process for Clinical Research Training
and Medical Education at the Clinical
Center and Its Impact on Course and
Training Program Enrollment and
Effectiveness (Clinical Center)
AGENCY:
National Institutes of Health,
HHS.
E:\FR\FM\30JNN1.SGM
30JNN1
39200
ACTION:
Federal Register / Vol. 85, No. 126 / Tuesday, June 30, 2020 / Notices
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30 days of the date of this
publication.
SUMMARY:
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, contact: Robert
M. Lembo, MD, Office of Clinical
Research Training and Medical
Education, NIH Clinical Center,
National Institutes of Health, 10 Center
Drive, Room 1N252C, Bethesda, MD
20892–1158, or call non-toll-free
ADDRESSES:
number (301) 496–2636, or Email your
request, including your address to:
robert.lembo@nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on April 16, 2020, page 21255–
21256 (85 FR 21255–21256) and
allowed 60 days for public comment.
One comment was received. The
purpose of this notice is to allow an
additional 30 days for public comment.
The Clinical Center, National
Institutes of Health, may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection Title:
Application Process for Clinical
Research Training and Medical
Education at the NIH Clinical Center,
OMB #0925–0698, Expiration date July
31, 2020, REVISION, National Institutes
of Health Clinical Center (CC), National
Institutes of Health (NIH).
Need and Use of Information
Collection: The primary objective of the
application process is to allow the
Office of Clinical Research Training and
Medical Education (OCRTME) at the
NIH Clinical Center to evaluate
applicants’ qualifications to determine
applicants’ eligibility for courses and
training programs managed by the
Office. Applicants must provide the
required information requested in the
respective applications to be considered
a candidate for participation.
Information submitted by candidates for
training programs is reviewed initially
by OCRTME administrative staff to
establish eligibility for participation.
Eligible candidates are then referred to
the designated training program
director/administrator or training
program selection committee for review
and decisions regarding acceptance for
participation. A secondary objective of
the application process is to track
enrollment in courses and training
programs over time.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours is
333.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Average
burden
per response
(in hours)
Total
annual
burden
hours
Type of respondents
Clinical Electives Program ................
Graduate Medical Education ............
Medical Research Scholars Program
Resident Electives Program .............
Bioethics Fellowship Program ..........
Pre Doctoral Students ......................
Physicians ........................................
Pre Doctoral Students ......................
Physicians ........................................
Pre Doctoral, Post-Doctoral .............
300
100
200
100
300
1
1
1
1
1
20/60
20/60
20/60
20/60
20/60
100
33
67
33
100
Total ...........................................
...........................................................
........................
1000
........................
333
Dated: June 25, 2020.
Laura M. Lee,
Project Clearance Liaison, NIH Clinical
Center, National Institutes of Health.
[FR Doc. 2020–14057 Filed 6–29–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
respondents
Form name
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
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The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Long-Term
Services for Dementia Care.
Date: July 17, 2020.
Time: 10:00 a.m. to 1:00 p.m.
PO 00000
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Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Video Meeting).
Contact Person: Kimberly Firth,
Ph.D.,Scientific Review Officer, Scientific
Review Branch, National Institute on Aging,
National Institutes of Health, Gateway
Building, 7201 Wisconsin Avenue, Suite
2W200, Bethesda, MD 20892, (301) 402–
7702, firthkm@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
E:\FR\FM\30JNN1.SGM
30JNN1
]]>Agencies
[Federal Register Volume 85, Number 126 (Tuesday, June 30, 2020)]
[Notices]
[Pages 39199-39200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14057]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30 Day Comment Request Application
Process for Clinical Research Training and Medical Education at the
Clinical Center and Its Impact on Course and Training Program
Enrollment and Effectiveness (Clinical Center)
AGENCY: National Institutes of Health, HHS.
[[Page 39200]]
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has submitted to the Office of
Management and Budget (OMB) a request for review and approval of the
information collection listed below.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 30 days of the date of
this publication.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, contact: Robert M. Lembo, MD, Office
of Clinical Research Training and Medical Education, NIH Clinical
Center, National Institutes of Health, 10 Center Drive, Room 1N252C,
Bethesda, MD 20892-1158, or call non-toll-free number (301) 496-2636,
or Email your request, including your address to: [email protected].
SUPPLEMENTARY INFORMATION: This proposed information collection was
previously published in the Federal Register on April 16, 2020, page
21255-21256 (85 FR 21255-21256) and allowed 60 days for public comment.
One comment was received. The purpose of this notice is to allow an
additional 30 days for public comment.
The Clinical Center, National Institutes of Health, may not conduct
or sponsor, and the respondent is not required to respond to, an
information collection that has been extended, revised, or implemented
on or after October 1, 1995, unless it displays a currently valid OMB
control number.
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction
Act of 1995, the National Institutes of Health (NIH) has submitted to
the Office of Management and Budget (OMB) a request for review and
approval of the information collection listed below.
Proposed Collection Title: Application Process for Clinical
Research Training and Medical Education at the NIH Clinical Center, OMB
#0925-0698, Expiration date July 31, 2020, REVISION, National
Institutes of Health Clinical Center (CC), National Institutes of
Health (NIH).
Need and Use of Information Collection: The primary objective of
the application process is to allow the Office of Clinical Research
Training and Medical Education (OCRTME) at the NIH Clinical Center to
evaluate applicants' qualifications to determine applicants'
eligibility for courses and training programs managed by the Office.
Applicants must provide the required information requested in the
respective applications to be considered a candidate for participation.
Information submitted by candidates for training programs is reviewed
initially by OCRTME administrative staff to establish eligibility for
participation. Eligible candidates are then referred to the designated
training program director/administrator or training program selection
committee for review and decisions regarding acceptance for
participation. A secondary objective of the application process is to
track enrollment in courses and training programs over time.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours is 333.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Type of Number of Number of burden per Total annual
Form name respondents respondents responses per response (in burden hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Clinical Electives Program.... Pre Doctoral 300 1 20/60 100
Students.
Graduate Medical Education.... Physicians...... 100 1 20/60 33
Medical Research Scholars Pre Doctoral 200 1 20/60 67
Program. Students.
Resident Electives Program.... Physicians...... 100 1 20/60 33
Bioethics Fellowship Program.. Pre Doctoral, 300 1 20/60 100
Post-Doctoral.
---------------------------------------------------------------
Total..................... ................ .............. 1000 .............. 333
----------------------------------------------------------------------------------------------------------------
Dated: June 25, 2020.
Laura M. Lee,
Project Clearance Liaison, NIH Clinical Center, National Institutes of
Health.
[FR Doc. 2020-14057 Filed 6-29-20; 8:45 am]
BILLING CODE 4140-01-P
